510(k) K211165 ยท FXX Mask, Surgical
Medical Face Masks, Model Name:MY020003
| Applicant | Huizhou Jie Bai Purification Co., Ltd., Huizhou, CN |
| Decision | Substantially Equivalent, Nov 9, 2021 |
| Received | Apr 19, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211165
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.